Context card
Task analysis across the documentation disciplines
Who uses task analysis, and which documents does it feed?
The short answer
Almost every documentation discipline, each for its own document: safety engineers for the risk assessment and the instruction handbook, regulatory teams for the usability file of medical devices, quality for SOPs and work instructions, R&D and PLM for requirements and the split between people and machines, technical writers for the instructions for use, roll-out teams for training, and operators for their own instructions. The analysis is similar; the purpose, audience and access of the result differ.
For: Documentation managers, safety and regulatory engineers, quality managers, technical writers, roll-out and training teams
Key points
- Safety: ISO 12100 identifies hazards by the tasks people perform in each life cycle phase; ISO 20607 requires the target groups and their tasks for the instruction handbook.
- Regulatory (medical devices): IEC 62366-1 works with use scenarios and hazard-related use scenarios; FDA human factors guidance speaks of critical tasks.
- Quality: SOPs and work instructions describe tasks on the manufacturer’s own production site.
- R&D and PLM: task analysis feeds user requirements, use cases and the allocation of tasks between people and machines.
- Technical writing: IEC/IEEE 82079-1 requires information for use that fits the target audiences’ expected tasks and goals.
- Roll-out, training and operators: training needs analysis and the operator’s own instructions start from the tasks on site.
The context
One method, many owners
Task analysis is not a technical writing method that other departments borrow, nor the reverse. Every discipline that writes about how people work with a product analyzes tasks — for its own document, audience and access level. Knowing which discipline owns an analysis explains why the same task appears in several documents with different wording.
| Discipline | What task analysis feeds | Typical document | Access |
|---|---|---|---|
| Safety engineering | Hazard identification per life cycle phase and task (ISO 12100); target groups and tasks (ISO 20607) | Risk assessment, safety parts of the instruction handbook | Internal; the handbook is handed over |
| Regulatory (medical devices) | Use scenarios, hazard-related use scenarios (IEC 62366-1); critical tasks (FDA) | Usability engineering file, summative evaluation | Internal, submitted to authorities or notified bodies |
| Quality | Tasks on the production site | SOPs, work instructions (quality documentation) | Internal, on the manufacturer's site |
| R&D and PLM | User requirements, use cases, task allocation between people and machines | URS, use case models, HMI concepts | Internal |
| Technical writing | Target audiences, their tasks and goals (IEC/IEEE 82079-1) | Instructions for use, help, quick guides | Handed over, sometimes public |
| Roll-out and training | Tasks of the operator's staff during commissioning and handover | Commissioning and handover documentation, training material | Handed over, restricted |
| Operator | Tasks at the operator's own workplaces, based on its risk assessment | Betriebsanweisung, operator SOPs, shift instructions | Operator-internal |
Why the distinctions matter
The terms differ: IEC 62366-1 speaks of hazard-related use scenarios, the FDA of critical tasks, the EU medical device regulations of neither. A task called "routine cleaning" in an SOP may be a hazard-related use scenario in the usability file and a procedure with a warning in the instructions. Sharing one task model across departments avoids contradictions, but each document still answers to its own rules and readers.
Task analysis shows where people may fail and what they need. It never proves that a product is safe or that a document complies with a regulation; that is decided by the requirements each document has to meet.
Questions readers ask next
- Can the instructions for use reuse the task analysis of the risk assessment?
- Yes, and they should start from it, because both look at the tasks of the same life cycle phases. The instructions still need audience-specific selection and wording.
- Is an operator SOP part of the manufacturer’s documentation?
- No. It is written by the operator for its own staff, often from the manufacturer’s instructions and the operator’s own risk assessment.
- Are "critical task" and "hazard-related use scenario" the same?
- They overlap but are not identical: the FDA term refers to a task, the IEC 62366-1 term to a scenario that can lead to a hazardous situation.
Sources
- ISO 20607:2019 Safety of machinery – Instruction handbook – General drafting principles (sample) — ISO, June 1, 2019
- Use scenario, critical user task, user story — Johner Institute, October 2, 2026
- IEC/IEEE 82079-1:2019 Preparation of information for use (instructions for use) of products – Part 1 — IEC, May 29, 2019
- § 12 BetrSichV Unterweisung und besondere Beauftragung von Beschäftigten — Bundesministerium der Justiz, October 2, 2026
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